GENERI BIOTECH

What GENERI BIOTECH does

GENERI BIOTECH s.r.o. is a privately held Czech biotechnological company founded in 1995 and headquartered in Hradec Králové, focused on the development, manufacture, and commercialization of real-time PCR (qPCR) and RT-PCR molecular diagnostic products. The company's commercial portfolio spans four business lines: CE IVD real-time PCR kits organized into five clinical categories (clinical genetics, hematology, pharmacogenetics, oncology, and microbiology) under product families gb HEMO, gb GENETIC, gb PHARM, gb ONCO, and gb MICRO; Life Sciences reagents and consumables including PCR/RT master mixes, DNA extraction kits, and human cell line authentication; custom oligonucleotide synthesis services with proprietary modifications such as GEMINI™ dual-labeled probes, SEQplus sequencing primers, patented alternative dyes (CFR 610, CFR 635), and BBQ650 quencher (US Patent 7,879,986); and GLP/GMP-compliant contract testing services for pharmaceutical and biotech sponsors including biodistribution studies, adenovirus-based studies, and gene therapy vector testing. The company also offers expert and anonymous paternity testing services to the public.

The business operates on a unit-pricing model for IVD kits (e.g., from €115 per gb ONCO EGFR kit), quote-based pricing for custom oligonucleotides and CRO services, and quote-based service fees for GLP/GMP testing. Go-to-market combines direct sales through a multilingual customer portal serving Czech and Slovak customers, an active worldwide distributor recruitment program, and recurring participation at major European trade fairs including MEDICA, analytica, and ESHG. Generi Biotech holds CE IVD marking, IVDR 2017/746 compliance, EN ISO 13485, ISO 9001, GLP, and GMP certifications, and completed a relocation to new production facilities with full recertification by August 2024.

The company sells into three primary verticals: clinical laboratories and healthcare providers (CE IVD diagnostic kits), pharmaceutical/biotech sponsors and CROs (GLP/GMP testing), and research institutions (custom oligonucleotides and reagents). Its kits are validated for compatibility across 18+ PCR cycler platforms from Applied Biosystems, Bio-Rad, Roche, Agilent, Qiagen, Cepheid, Sansure, and others, reducing customer integration friction. Founded in 1995, Generi Biotech has operated for nearly three decades without disclosed external institutional funding rounds, acquisitions, or parent company, indicating organic, self-funded growth led by R&D investment in proprietary chemistry and IVD product extensions.

Name

GENERI BIOTECH

Legal name

GENERI BIOTECH s.r.o.

Website

https://generi-biotech.com

Company type

Private

Founded year

1995

Operating status

Operating

Headcount range

11–50 employees

Short description

Generi Biotech is a Czech biotechnological company (founded 1995) that develops, manufactures, and sells CE IVD real-time PCR diagnostic kits, custom oligonucleotides and probes, and GLP/GMP contract testing services for clinical laboratories, pharmaceutical sponsors, and research institutions.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics (Real-time PCR IVD Kits)

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical and Diagnostic Laboratories (6215), Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047)

akta.pro primary industry

Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF)

akta.pro secondary industries

Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Genomics & Molecular Diagnostics (Trial Support) (HLAGAEAD), Molecular Diagnostics (PCR/qPCR, NGS-based assays) (HLAAALAA), Molecular Biology & Genomics Instruments (PCR/qPCR, Sequencing, Microarrays) (HLAGAIAF)

Keywords

• Real-time PCR diagnostics
• CE IVD kits
• Pharmacogenetics testing
• Custom oligonucleotide synthesis
• GLP/GMP testing services

Headquarters

HQ city

Hradec Kralove

HQ country

Czechia

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Supply Chain, Marketing or Sales, Infrastructure

Revenue model

1. CE IVD Diagnostic Kits: Sale of CE IVD certified real-time PCR diagnostic kits for clinical genetics, hematology, pharmacogenetics, oncology, and microbiology applications. Products include gb HEMO, gb GENETIC, gb PHARM, gb ONCO, and gb MICRO product lines.
2. Life Sciences Products: PCR/RT Master Mixes, DNA extraction kits, PCR plastic consumables, and cell line authentication products for research applications.
3. Custom Oligonucleotide Synthesis: Custom synthesis of oligonucleotides including primers, probes, NGS primers, ultramers, and modified oligonucleotides with various fluorescent dyes and quenchers. Includes patented alternative dyes like CFR 610, CFR 635, and BBQ650 quencher.
4. GLP/GMP Testing Services: Contract testing services for preclinical and clinical drug development including biodistribution studies, adenovirus-based studies, and gene therapy vector testing for pharmaceutical and biotech clients.
5. Paternity Testing Services: Expert witness paternity tests for courts and private individuals, providing legally admissible genetic testing services.

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels4 records

Core offering

GENERI BIOTECH researches, manufactures, and sells its own proprietary real-time PCR (qPCR/RT-PCR) CE IVD diagnostic kits covering clinical genetics, hematology, pharmacogenetics, oncology, and microbiology, alongside custom-synthesized oligonucleotides and probes (including patented dyes and the GEMINI™ and BBQ650 quencher chemistries), life-science PCR reagents and master mixes, and GLP/GMP-compliant contract testing services for drug-development and gene-therapy programs. Products are sold under proprietary brand lines (gb HEMO, gb GENETIC, gb PHARM, gb ONCO, gb MICRO) and validated across more than 18 major PCR cycler platforms, with additional paid paternity-testing services for courts and private individuals.

Product overview

GENERI BIOTECH is an EU-located biotechnological company offering a comprehensive portfolio of products organized into four main categories: IVD Kits (CE-IVD and RUO real-time PCR diagnostic kits for clinical genetics, hematology, pharmacogenetics, oncology, and microbiology), Life Sciences Products (PCR/RT Master Mixes, DNA extraction kits, and cell line authentication services), Oligonucleotides & Probes (custom synthesis, modified oligos, NGS primers, GEMINI™ probes, SEQplus sequencing primers, ultramers, and patented dye alternatives), and CRO Services (GLP/GMP testing for drug development including biodistribution studies and gene therapy vector testing). The company also offers public testing services including expert and anonymous paternity testing.

Differentiator

Problem solved

Functional benefit

Products and services

• gb HEMO Real-time PCR IVD Kits (Thrombophilia / Hematology) CE IVD real-time PCR kits for detection of thrombophilia- and hematology-related mutations including Factor V Leiden (G1691A), Factor II prothrombin (G20210A), MTHFR (C677T, A1298C), PAI1 (4G/5G), GPIIIa (L33P), GPIa (C807T), and Factor XIII (V34L) using fluorescently labelled probes and allelic discrimination. For clinical laboratories performing routine coagulation genetics testing.
• gb GENETIC Real-time PCR IVD Kits (Clinical Genetics) CE IVD real-time PCR kits for clinical genetics testing including HLA-B*27 (ankylosing spondylitis), LACTO (lactase LCT C13910T/G22018A), FRUCTO (ALDOB A149P/A174D/N334K), HFE (C282Y/H63D/S65C), Gilbert syndrome (UGT1A1 TA repeat), A1AT (PI*S/PI*Z), APOE (rs429358/rs7412; Alzheimer's and cardiovascular risk), APOB R3500Q, SRY gene detection, and POLR2A-based human-DNA quantification (forensic use). Designed for hospitals and clinical labs serving genetic-medicine workflows.
• gb PHARM Real-time PCR IVD Kits (Pharmacogenetics) CE IVD real-time PCR kits for pharmacogenetics-guided therapy personalization: TPMT (*2/*3A/*3B/*3C) for thiopurine dosing, DPYD (*2A/*13/HapB3/c.2846A>T) per CPIC/DPWG for fluoropyrimidine dosing, CYP2C19 (*2/*3/*17) for clopidogrel, Warfarin (CYP2C9*2/*3 and VKORC1 G1639A), UGT1A1 (5TA/6TA/7TA/8TA) for irinotecan/toxicity, and BCHE (A, K, F1, F2, S1 polymorphisms) for butyrylcholinesterase deficiency and myorelaxant metabolism. For clinical pharmacogenetics laboratories and hospital pharmacies.
• gb ONCO Real-time PCR IVD Kits (Oncology) CE IVD (and selected RUO) real-time PCR kits for oncology mutation detection and monitoring: EGFR (40 individual mutations across 7 groups in exons 18-21 for TKI selection), EGFR T790M (2369C>T) for resistance monitoring, BRAF V600E / V600 panels, CLL prognosis via reverse-transcription qRT-PCR, JAK2 V617F (RUO), and BCR-ABL1 fusion transcript quantitation (Major/Minor/Micro with ABL or GUSB reference) plus BCR-ABL1 Detect qualitative rare-variant kit. For molecular oncology labs and clinical hematology units.
• gb MICRO Real-time PCR IVD Kits (Microbiology) CE IVD real-time PCR kit for detection and quantification of pathogenic Aspergillus DNA (A. fumigatus, A. flavus, A. niger, A. terreus). For clinical microbiology laboratories performing invasive aspergillosis diagnostics.
• STANDARD MMR BCR-ABL MAJOR (RNA Reference Standard) RNA reference standard with precisely defined copy-number ratio of BCR-ABL1 MAJOR (b3a2) and reference genes ABL1 and GUSB transcripts, used to convert local qRT-PCR results to the International Scale. For BCR-ABL molecular monitoring laboratories.
• PCR/RT Master Mixes (Life Sciences) Hot-start Taq DNA polymerase-based master mixes for real-time PCR including Ideal PCR Master Mix, SG PCR Master Mix, and OneStep RT-qPCR Kit, offered with optional integrated Internal Positive Control (IPC) for verification of PCR success. For research laboratories using qPCR and RT-qPCR.
• Kit for Isolation of DNA from Body Fluids DNA extraction kit for purification of genomic DNA from whole blood, serum, plasma, buccal swab, and urine, including viral DNA isolation. For molecular-biology and clinical-research laboratories performing downstream PCR/qPCR.
• Human Cell Line Authentication on LabCard Authentication service for human cell lines using GENERI BIOTECH LabCard technology to confirm cell-line identity and detect contamination. For academic and industrial cell-culture laboratories.
• Custom Oligonucleotide Synthesis Custom synthesis of oligonucleotides including primers, probes, NGS primers, ultramers, and modified oligonucleotides with various fluorescent dyes and quenchers for research and diagnostic applications. Supports 2'-F-RNA, 2'-OMe-RNA, phosphorothioates, fluorescent dyes (6-FAM, HEX, ROX, Cy3, Cy5, TET, JOE), and quenchers (BBQ650, BHQ1/2/3).
• NGS Primers Next-generation sequencing primers for various NGS applications, available through the catalog and custom-ordering workflows.
• GEMINI™ Dual-Labeled PCR Probes Patent-protected dual-labeled RT-PCR probes with unique dye combinations for multiplex real-time PCR applications; trademarked as GEMINI™. For research and diagnostic laboratories performing multiplex qPCR.
• SEQplus Universal Sequencing Primers Stock sequencing primers for Sanger sequencing applications, with proprietary modifications for enhanced performance. For sequencing core facilities and genetics laboratories.
• Ultramers Long oligonucleotides exceeding 100 bases for complex experimental designs including long control templates, specific probes, and advanced genetic manipulations. Available through the GENERI BIOTECH custom-oligo ordering flow.
• Patented Alternative Dyes for Oligonucleotide Labeling (CFR 610, CFR 635) Patent-protected alternative fluorophores CFR 610 and CFR 635 providing cost-effective alternatives to branded dyes (e.g., Alexa, Cy equivalents) while maintaining equivalent performance in qPCR and other labeling applications. Configurable on custom oligos at unit pricing (e.g., starting from €45 for 40 nmol scale, EU).
• GLP/GMP Contract Testing Services (Biodistribution, Adenovirus-based, Gene Therapy Vector Testing) GLP-compliant biodistribution studies for nucleic acids (DNA/RNA) using qPCR, GLP-compliant adenovirus-based study support, and GMP/GLP testing services for gene-therapy vectors including plasmid tests. Delivered as CRO services for pharmaceutical and biotech sponsors.
• Expert and Anonymous Paternity Testing Services Expert-witness paternity tests with legally admissible reports for courts (priced at 15,488 Kč incl. VAT plus 5,600 Kč expert witness fee, with 10% advance-payment or 20% on-site Hradec Králové pickup discounts available), plus anonymous paternity testing for private individuals.

Quantifiable outcome

• Detection of 40 individual EGFR mutations across 7 mutation groups in single kit
• +1 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration17 records

Feature5 records

Scale indicators3 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Sacace Biotechnologies: Italy-based molecular diagnostics company focused on real-time PCR kits (infectious disease, genetic, oncology), most comparable as a similarly sized European CE-IVD qPCR specialist.
• Diagenode (Hologic): Belgian molecular diagnostics developer (now part of Hologic) producing real-time PCR reagents and assays — comparable as another European CE-IVD qPCR reagent/kit maker with similar end-user customers.
• ELITech Group: European diagnostics specialist producing CE-IVD molecular diagnostic kits (incl. genetics, microbiology, pharmacogenetics) — directly overlapping with Generi's CE-IVD portfolio and European hospital-lab customer base.
• TIB Molbiol (Roche): Historically an independent Berlin-based specialist in CE-IVD real-time PCR kits (now owned by Roche Diagnostics) covering infectious disease, hereditary, pharmacogenetics and oncology — essentially the same specialty CE-IVD qPCR niche Generi Biotech occupies.

Broad incumbents

• Roche Diagnostics: World-leading diagnostics organization across PCR (cobas, LightCycler) and companion diagnostics; Generi's LightCycler/Cobas validations show the overlap, and Roche's acquisition of TIB Molbiol makes it the most relevant incumbent competitor in Generi's CE-IVD niche.
• Bio-Techne / ExoDx: Through its molecular diagnostics and bioscience reagent portfolio (incl. predecessor Exiqon, ExoDx and protein biology offerings), Bio-Techne serves molecular biologists with research-use qPCR reagents and genetic test components, broadly comparable to Generi's life-sciences and oligo product lines.
• Qiagen: Global molecular diagnostics and sample-preparation powerhouse providing PCR reagents, IVD assays and Rotor-Gene cyclers that Generi has validated as compatible, competing across many of the same disease areas and labs.
• Bio-Rad Laboratories: Major life science and clinical diagnostics company whose real-time PCR cyclers and reagents compete head-to-head with Generi's kits; Generi even validates several Bio-Rad CFX platforms, indicating direct overlap in clinical-lab workflows.
• Eurofins Genomics: Europe-based custom oligonucleotide synthesis and molecular-biology services provider competing with Generi's life-sciences and oligo synthesis business across both standalone oligos and GMP DNA/RNA production.
• Eurofins Pharma Bioanalytical Services: Large international bioanalytical and GLP/GMP CRO division of Eurofins that competes directly with Generi's GLP/GMP biodistribution and gene therapy vector qPCR testing services for pharmaceutical sponsors.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/generi-biotech

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about GENERI BIOTECH